FDA Device recall Z-3097-2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve… by Siemens Medical Solutions Usa, citing due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3097-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-18 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Reason
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Identifiers
| code_info | Artis zee multi-purpose - Serial number: 157660 158170 130017 157698 158108 157657 157988 157690 158091 157616…Artis zee multi-purpose - Serial number: 157660 158170 130017 157698 158108 157657 157988 157690 158091 157616 157710 158132 157677 157615 157700 157977 157602 158183 157642 158121 157975 157969 157579 157573 157650 157671 157713 158080 130013 157928 157696 157989 157644 157648 157999 158066 158180 158032 158134 130019 157601 157992 157625 158079 157600 157604 157634 157635 158081 158104 158105 158056 157965 157570 157658 157594 158027 157706 158042 157674 157907 158043 157668 158019 157692 157936 157984 158113 157707 157708 157661 157688 158136 157987 158028 157702 158191 158138 158126 157704 158186 157667 158133 157645 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3097-2017%22
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